| CTRI Number |
CTRI/2021/02/031384 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of acne(pimples) scars with Radiofrequency(new technology). |
|
Scientific Title of Study
|
Efficacy and Safety of Microneedling Radiofrequency in acne scars |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Prasad Chowdary |
| Designation |
Professor and Head of the department,GSL Medical College and General Hospital. |
| Affiliation |
GSL Medical College and General Hospital |
| Address |
Room no 23,Department of DVL, GSL Medical Colleges and General Hospital, Lakshmipuram,NH16, Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9246655555 |
| Fax |
|
| Email |
arumilliskin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Prasad Chowdary |
| Designation |
Professor and Head of the department,GSL Medical College and General Hospital. |
| Affiliation |
GSL Medical College and General Hospital |
| Address |
Room no 23,Department of DVL, GSL Medical Colleges and General Hospital, Lakshmipuram,NH16, Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9246655555 |
| Fax |
|
| Email |
arumilliskin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Undavalli Navya devi |
| Designation |
MD-DVL GSL Medical College and General Hospital,Rajahmundry |
| Affiliation |
PG student ,GSL Medical College and General Hospital,Rajahmundry |
| Address |
Room no 23,Department of Dermatology Venereology and Leprosy,GSL Medical College and General Hospital, Lakshmipuram, NH16, Rajahmundry
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
8985603435 |
| Fax |
|
| Email |
Navya.undavalli23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL GSL Medical College and General Hospital Rajahmundry Andhra pradesh |
|
|
Primary Sponsor
|
| Name |
GSL Medical College and General Hospital |
| Address |
Lakshmipuram NH16 Rajahmundry |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Undavalli Navya devi |
GSL Medical college and General Hospital |
Room no 23,Department of Dermatology Venereology and Leprosy,GSL Medical College and General Hospital,Lakshmipuram,NH16,Rajahmundry
East Godavari
ANDHRA PRADESH |
8985603435
Navya.undavalli23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - GSL Medical college and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MICRONEEDLING RADIOFREQUENCY BY LUMENIS LEGEND PRO MACHINE |
LUMENIS LEGEND PRO Radiofrequency machine is used. non insulated ultra thin needle GEN 36 or GEN 36 L will be selected based on the type of acne scars. Exposure from 15-20% of the scar area each time.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group 18-55years of both sex with acne scars |
|
| ExclusionCriteria |
| Details |
Patients with bleeding and clotting disorders, on anticoagulant therapy,with uncontrolled diabetes and collagen vascular disease,with verruca vulgaris solar keratosis or any cancer with history of topical acne treatment 1month before the study ,who underwent any aesthetic procedure on the face within 6 months ,metal implants in the treatment area ,pregnant and lactating women ,with other active concurrent skin lesions on the face ,who are not willing to participate voluntarily ,with unrealistic expectations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will know whether this study will help us to know Microneedling Radiofrequency is efficacious and safe in treatment of acne scars |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will also pave a new, updated and short term treatment of acne scars |
18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acne scars are the most distressing and undesirable complications of acne .These scars originate at the site of injury induces loss or excess collagen resulting in atrophic and hypertrophic scars, by using microneedling Radiofrequency the micro needles delivers Radiofrequency currents and creates small zones of neocollagenogenesis ,also causes dermal remodeling and neoelastogenesis. Device used is LUMENIS LEGEND PRO Microneedling radiofrequency machine. This trial is a hospital-based, prospective interventional study. sample size is 40 . Informed and written consent will be taken for the procedure. Patient will be undergoing 4 sessions of Microneedling Radiofrequency with an interval of 3 weeks between each session. Follow up will be done at each session and 4 weeks after the last lession. clinical assessment is done by Patient skin type, Physician global assessment (PGA), Patient satisfaction score(PSA).Objective assessment is by Clinical photographs and Improvement of the grade will be assessed by Goodman and Baron’s qualitative and quantitative acne scar grading. |